Seattle Genetics, Inc. (Nasdaq: SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) today announced completion of patient enrollment in the ECHELON-2 clinical trial. ECHELON-2 is a global phase 3 randomized trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-positive mature T-cell lymphoma (MTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on several types of non-Hodgkin lymphoma, including subsets of MTCL, as well as Hodgkin lymphoma. ADCETRIS is currently not approved for the frontline treatment of MTCL.

Patients in ECHELON-2 were randomized to receive a novel combination regimen consisting of ADCETRIS plus cyclophosphamide (C), doxorubicin (H) and prednisone (P) (referred to as A+CHP) versus cyclophosphamide, doxorubicin, vincristine (O) and prednisone (referred to as CHOP), the recognized standard of care treatment regimen for frontline MTCL. The trial enrolled 452 patients. The ECHELON-2 trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and the trial also received European Medicines Agency (EMA) scientific advice.

"Our goal is to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas and redefine frontline treatment in Hodgkin lymphoma and MTCL through our broad, late-stage clinical development program currently underway. The ECHELON-2 clinical trial represents our fourth phase 3 study to complete enrollment," said Naomi Hunder, M.D., Vice President, Clinical Development at Seattle Genetics. "We look forward to the results of the ECHELON-2 frontline MTCL study in the 2017 to 2018 timeframe and expect to refine the timeline in the future. The ultimate goal of this phase 3 trial is to improve outcomes for frontline patients with CD30-expressing MTCL and, if the trial results are positive, to submit data from this trial to regulatory agencies to expand the label for ADCETRIS use in the frontline setting."